BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL DRILL BITS AND ACCESSORIES

    MDR report key: 9713011 · Received February 14, 2020

    Report

    Report Number
    2183456-2019-00023
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 8, 2018
    Report Date
    February 14, 2020
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    HBE
    UDI-DI
    00841823106520
    PMA / PMN Number
    K170442
    Removal / Correction Number
    2183456-08212019-R-004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 2183456-2019-00023 HAS BEEN FILED PAST THE 30-DAY TIMEFRAME. THROUGH THE 2019 FDA INSPECTION, IT WAS IDENTIFIED THAT WHILE AD-TECH WAS EVALUATING REPORTABILITY FOR ACTUAL EVENTS IN WHICH DEATH OR SERIOUS INJURY HAD OCCURRED, AD-TECH HAD FAILED TO SUBMIT EVENTS IN WHICH A MALFUNCTION WAS REPORTED AND COULD RESULT IN A SERIOUS INJURY IF THE EVENT WERE TO RECUR. AS PART OF THE INVESTIGATION, A TWO (2) YEAR RETROSPECTIVE REVIEW OF COMPLAINTS WAS PERFORMED TO DETERMINE WHICH COMPLAINTS REQUIRED SUBMISSION OF AN MDR. MDR-2183456-2019-00023 WAS SUBMITTED AS A CONSERVATIVE MEASURE DUE TO THE RECALLS TIED TO THIS ISSUE.

    Description of Event or Problem · 1

    AT A CASE ATTENDED BY AD-TECH CLINICAL SPECIALISTS THE DRILL BIT FUSED WITH THE GUIDE ON THE 4TH TRAJECTORY. THERE WAS NO PATIENT HARM AND THE CASE PROCEEDED WITH ANOTHER DRILL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174897 CRANIAL DRILL BITS AND ACCESSORIES DRILL SLEEVE GUIDE HBE AD-TECH MEDICAL INSTRUMENT CORP. DSG-6.3-090-2.4N 715001 00841823106520

    Patients

    Seq Age Sex Outcome Treatment
    1 Other